Angelica sinensis and radix astragali particles and preparation method thereof

[0022] The present invention will be further described below through specific examples. The following examples are intended to enable those skilled in the art to better understand the present invention, but do not limit the present invention.

[0023] A Guiqi granule, the active ingredient contained in the granule is composed of the following raw materials by weight: 1 part of Angelica sinensis and 5 parts of Astragalus root.

[0024] The production method of above-mentioned Guiqi granules, comprises the steps:

[0025] (1) Pre-treatment of medicinal materials: spray and wash the medicinal materials of Angelica sinensis with a washing machine until it is clean. Cleanliness inspection: Take an appropriate amount of washed medicinal materials, rinse in a 500ml beaker containing about 300ml of drinking water, check the washing water, and there should be no sediment. Send the qualified Angelica medicinal materials to the cutting process: slice the Angelica sinensis (the thickness is 6-15 mm, and check the thickness at the beginning, middle and end of the cutting process), and dry the cut Angelica medicinal materials.

[0026] (2) Extraction: Weigh the Astragalus (prepared) and the Angelica treated in step (1) according to the formula, then place the whole amount in a multi-functional extraction tank and add water to decoct twice, and for the first time, add 9.5 times the amount of water to soak 2 After 1 hour, decoct for 2 hours; add 8 times the amount of water for the second time, decoct for 2 hours, filter and pump into the tank through a filter, and let the filtrate stand. Liquid inspection: at the sampling port behind the filter, use a 250 ml conical flask to take about 100 ml of the liquid medicine, and observe with the naked eye that there should be no precipitation.

[0027] (3) Initial concentration: transfer the supernatant obtained in step (2) into a single-effect vacuum concentration tank, control the temperature to be 55 to 60°C, the vacuum degree to be -0.02 to -0.08Mpa, and concentrate under reduced pressure to a relative density of The initial concentrate of 1.10.

[0028] (4) Alcohol precipitation: carry out alcohol precipitation on the initial concentrated solution obtained in step (3), add 95% ethanol to make the alcohol content reach 50%, stand for 24 hours, and filter to obtain an alcohol-containing solution.

[0029] (5) Concentrating and collecting paste: after recovering ethanol from the alcohol-containing solution obtained in step (4), the concentrated solution is transferred into a spherical vacuum concentration tank, and the temperature is controlled to be 55 to 60°C, and the vacuum degree is -0.02 to -0.08Mpa. The wet extract was concentrated to a relative density of 1.30 by pressing.

[0030] (6) Preparation of extract powder: add 1.5 times the amount of dextrin to the wet extract prepared in step (5), mix it evenly, and spread it evenly in a baking tray. The thickness of each tray of extract is 2-3 cm. Put it into a vacuum drying oven to dry from top to bottom, control the drying temperature to be 55-65 °C, and the drying time to be 10 to 12 hours. When the temperature rises to 60 °C, start timing, pulverize the obtained dry extract, and pass it through an 80-mesh sieve. Net, that is, extract powder, ready to use; because dextrin has good anti-hygroscopicity, low price, and good water solubility after being made into granules, so dextrin is selected as an auxiliary material.

[0031] (7) Crushing, weighing, and batching of raw and auxiliary materials: crush the powdered sugar and available materials (the head after each batch of granulation) through an 80-mesh sieve and weigh; In the container of the plastic bag, the bag mouth is fastened down, and the inner and outer labels are attached. If there is available material, the addition amount should not exceed 10% of the total amount of the material, and it should not be more than two batches. Powdered sugar is cheap and has good water solubility. Sucrose powder is selected as an auxiliary material to play the role of a flavoring agent.

[0032] (8) Mixing: Put the extract powder and raw and auxiliary materials in a mixer and stir for 10 minutes, add 90% ethanol as a wetting agent, and stir for 5 minutes to obtain a soft material.

[0033] (9) Making wet granules: The soft material obtained in step (8) was made into wet granules with a 14-mesh screen using a swing granulator.

[0034] (10) Drying: Immediately and evenly spread the wet granules obtained in step (9) in the stainless steel baking pan, control the thickness of the wet granules in the baking pan to be 2-3 cm, place them on the drying car in the order from top to bottom, push the Dry in a vacuum dryer, and dry at 60 °C for 6 hours, control the moisture content of the particles to be ≤4.0%; pull the dried particles out of the oven to reduce the temperature of the material to room temperature.

[0035] (11) Granulation: put the dried granules obtained in step (10) into a crushing granulator, pass through a 14-mesh sieve to granulate, weigh and record.

[0036] (12) Mixing: put the granulated granules in step (11) into a three-dimensional motion mixer (the filling volume in the mixer should not exceed two-thirds of the total volume of the machine), mix for 10 minutes, and mix good pellets in containers.

[0037] (13) Sifting: Pass the mixed dry granules through 10-mesh and 60-mesh sieves to remove coarse and fine powders, send them to the intermediate station, take samples for testing, and enter the packaging after passing the test.

[0038] (14) Particle packaging and storage: According to the batch packaging instructions, receive the aluminum-plastic composite film material and the inspected particles. After installing the aluminum-plastic composite film material, adjust the longitudinal sealing temperature of the packaging machine to 150°C-160°C and the horizontal sealing temperature to 165°C-180°C. When the heating temperature of the packaging machine is at the set value, the aluminum-plastic composite film is air-sealed to pass. During the sub-packaging process, check the filling quantity every 15 minutes and check the sub-packaging quality at any time. This product is a traditional Chinese medicine granule. It should prevent moisture absorption and deterioration from affecting the quality of the preparation. Therefore, the selection of packaging materials is very important. It is packaged in aluminum-plastic composite bags, which can not only prevent moisture, but also prevent microbial contamination, so as to achieve the purpose of stabilizing the quality of the preparation and clinical efficacy. . In order to avoid moisture absorption of particles during the packaging process, the temperature and humidity of the production environment should be strictly controlled.

[0039] 1. The following is the optimization experiment of the process conditions:

[0040] 1. Experiment to optimize the water addition ratio in step (2):

[0041] (1) Experiment on water absorption rate of Guiqi medicinal materials: take 50 g of medicinal materials according to the prescription and put them into a beaker, add 1000 ml of water to soak, and observe the phenomenon of the medicinal materials moisturizing. The result is that the medicinal materials are completely moistened after 2 hours, and 924 ml of the infusion solution is filtered out, and the water absorption is calculated. The multiple is about 1.5 times;

[0042](2) Water addition test for extracting Guiqi medicinal materials: take 1000 g of medicinal materials according to the prescription, pulverize the medicinal materials into coarse powder, add 6, 8, 10, and 12 times the amount of water respectively, and decoct twice for two hours each time. Combine the decoction, filter, let the filtrate stand, take the supernatant and concentrate the clear paste to 1.10 (55-60°C), add ethanol to make the alcohol content 50%, stir well, let stand, filter, and the filtrate is recovered under reduced pressure Ethanol, and then concentrated to a relative density of 1.30 (55 ~ 60 ℃) extract. The content of Astragaloside IV was measured by taking Qing Gao according to the method under the Chinese Pharmacopoeia 2000 edition of Astragalus, and the results in Table 1 showed that it was better to add 8 times of water to extract,

[0043] .

[0044] 2. Screening for the proportion of dextrin added in step (6):

[0045] It is difficult to directly dry the extract obtained after recovering ethanol, so an appropriate amount of dextrin is added to the extract for drying to reduce drying time and improve drying quality. Therefore, the amount of dextrin was screened, and the results are shown in the following table. Taking into account the difficulty of powdering, drying time, and powder yield, and minimize the amount of auxiliary materials, choose 1.5 times the amount of dextrin,

[0046] .

[0047] 3. Screening for the proportion of powdered sugar added in step (8):

[0048] On the premise of ensuring the quality of the preparation, the dosage of excipients should be minimized to reduce costs and dosage. Add an appropriate amount of powdered sugar to the extract, and then use 90% ethanol as a wetting agent to granulate this product as a granule.

[0049] .

[0050] The above test results show that when there is less powdered sugar, the granulation is not easy, the taste is bitter and the yield is low. When the amount of powdered sugar is about 0.75 times, the taste is sweeter, and the yield is also over 95%. Taking into account the specifications of the finished product, the amount of auxiliary materials of about 0.75 times the amount of powdered sugar can be basically determined.

[0051] Two, the following is the embodiment of preparing Guiqi granules according to the present invention,

[0052] ,

[0053] .